Z-1597-2020 Class II Ongoing
FDA device recall Z-1597-2020 was initiated by Elekta Impac Software on September 24, 2019 and is designated Class II. Reason for recall: The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units. The recall status is ongoing. Affected quantity: 3732 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- September 24, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3732 units
Product Description
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Reason for Recall
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Distribution Pattern
Worldwide distribution.
Code Information
Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305); MOSAIQ 2.20 (00858164002312); MOSAIQ 2.30 (00858164002329); MOSAIQ 2.40 (00858164002077); MOSAIQ 2.41 (00858164002084); MOSAIQ 2.60 -2.64 (00858164002091); MOSAIQ 2.50 (00858164002107); MOSAIQ 2.65 (00858164002220); MOSAIQ 2.70 (00858164002037); MOSAIQ 2.80 (00858164002251); MOSAIQ 2.81 (00858164002282)